Biocon Gets a Form 483 From US FDA: The United States Food and Drug Administration (US FDA) has issued the form 483 with 10 observations to the Biopharmaceutical firm Biocon which has been found lapses in current Good Manufacturing Practices in Bengaluru. The regulation earlier has given the form with eight observations in the month of April.
The US FDA conducted the inspection in Biocon between May 25 and June 3. They issued the form 483 which consists of a list of violations that occurred in the sterilization and aseptic conditions in the manufacturing unit of Biopharmaceutical products. The US FDA inspections are very rigorous in the manufacturing unit when it comes to the injectable plants.
The US FDA issued the 483 form to the Biocon and the document includes the same drug products are in discrepancy among different batches and there is no adequate sterilization process is done to prevent microbial contamination. The report says that there is no proper cleaning and maintenance of the equipment. The quality control department lacks their authority to approve and reject the components as the employees in this department are not well trained and inexperienced.
The report said that the inspection of US FDA in the month of May and June are the regulatory periods of the audits for the small molecule injectable plants. The company has responded to the regulator with a Corrective and Preventive Action Plan (CAPA) and is on track to implement them in a timely manner. The company has taken these observations into considerations and they are in the correcting measures of their lapses in the manufacturing unit.